Actively Recruiting

Phase 3
Age: 14Years - 80Years
All Genders
ID06558981

The Role of Adjuvant Radiotherapy in High Risk Locally Advanced Differentiated Thyroid Cancer: a 1:1 Randomized Phase III Clinical Trial

Led by Fudan University · Updated on 2026-02-27

124

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the role of additional radiotherapy after surgery for patients with high-risk, locally advanced differentiated thyroid cancer. It is a phase III randomized controlled clinical trial comparing two treatment approaches to see which better prevents cancer recurrence in the lymph nodes and surrounding areas. The study focuses on patients who have had surgery but still have residual cancer tissue, assessing the impact of adding radiotherapy to standard radioiodine therapy (RAI). Participants are randomly assigned to one of two groups: the experimental group receives both radiotherapy and RAI, while the control group receives only RAI. Radiotherapy involves external radiation using advanced techniques such as intensity-modulated radiation therapy (IMRT) or volume modulated radiation therapy (VMAT) within six weeks after surgery. Both treatments are administered within six months after surgery. During the study, participants will be monitored for at least five years after surgery to measure outcomes including local-regional recurrence-free survival, recurrence rates, progression-free survival, overall survival, adverse effects, and quality of life. Researchers will conduct regular follow-ups to assess these outcomes and track participants’ health and treatment response over this period. The total participation duration extends through these long-term evaluations to gather comprehensive safety and effectiveness data.

CONDITIONS

Brief Title

Adjuvant Radiotherapy in High Risk Locally Advanced DTC

Who Can Participate

Age: 14Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient voluntarily agrees and signs informed consent
  • Age 14 years or older and under 80 years, any gender
  • Histopathological diagnosis of differentiated thyroid cancer
  • Underwent total or near total thyroidectomy
  • Surgery did not achieve complete tumor removal; residual tumor volume less than 2 cm3 if applicable
  • Normal main organ functions
  • Good compliance and cooperation with follow-up
Not Eligible

You will not qualify if you...

  • Previous radiation therapy to the head or neck area
  • Differentiated thyroid cancer with poorly differentiated or undifferentiated components
  • Presence of distant metastasis
  • Previous 131I treatment
  • Previous or current targeted therapy, immunotherapy, or chemotherapy
  • Other active malignant tumors within 5 years or simultaneously, except certain cured local tumors
  • Pregnant or lactating women
  • Other physical illnesses affecting ability to receive standard treatment
  • Serious illnesses or social/family factors affecting safety or data collection
  • Claustrophobia preventing radiation therapy
  • Deemed unsuitable by attending physicians for other reasons

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 6 months after surgery

Participants receive either radiotherapy combined with radioiodine treatment or radioiodine treatment alone within 6 months after surgery.

Follow-up

Duration - Up to 5 years after surgery

Participants are monitored for outcomes including recurrence, survival, adverse events, and quality of life for up to 5 years after surgery.

Trial Site Locations

Total: 1 location

1

Fudan Univeristy Shanghai Cancer Center

Shanghai, China

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Research Team

N

Naisi Huang, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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